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Which nomenclature system will be selected for MDR/IVDR?

  • Posted by: inetika
  • Category: GLOBAL NEWS

There was a time that many people in the healthcare workspace considered that the only option for a nomenclature system to be used for EUDAMED II, which underpins the new Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), would be the Global Medical Device Nomenclature (GMDN), but rumours are that this may no longer be the case.

Both the MDR and IVDR enshrine the principle that whichever nomenclature system is selected, it must be freely available to all stakeholders, and this has been a problem for GMDN, which since its inception over 20 years ago has charged for the issue of codes to device manufacturers.

The options now appear to include a new nomenclature being developed by the World Health Organisation (WHO), and a system being run by one of the European member states – the Italian ‘Classificazione Nazionale Dispositivi Medici’ (CND) system, which has been in operation in the country for many years, pre-dating even the device directives.

The WHO system will be known as the International Classification of Medical Devices (ICMD), progress towards which was discussed at the WHO 4th Global Forum on Medical Devices, which took place in December 2018. An example site to showcase ICMD is now available for browsing. WHO’s 2018 survey on medical device nomenclatures received a total of 43 responses, with 23 offers to collaborate or provide feedback and 11 different systems of nomenclature proposed for ICMD. “The nomenclature and classification of medical devices is an ongoing priority item for the WHO Medical Devices unit” in order to “progress towards access to medical devices to achieve universal health coverage and facilitate emergency interventions,” the agency said. WHO reported that 90 countries have an official nomenclature for medical devices, but the approaches to system implementation varied, as 26% were nationally developed, 12% only use the Universal Medical Device Nomenclature System (UMDNS) and 10% only use the GMDN.

The Italian CND system is freely available to all stakeholders, and the coding list has been available in dual language, Italian and English, since 2016. In addition, a conversion table with GMDN codes already exists. According to an Italian Notified Body, that the CND system is likely to be selected for EUDAMED, because it is established, complete and access is free, but clearly we will have to wait and see whether this is how things turn out.

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